Clinical trial of the effect of vitamin D supplementation compared with the placebo on recurrence and metabolic profiles in women with cervical intraepithelial neoplasia 2 and 3
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Protocol summary
Objective: The aim of this study is to determine the effects of vitamin D supplementation on recurrence and metabolic profiles in women with cervical intraepithelial neoplasia 2 and 3. Study design: Parallel double-blind (both participants and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Women with cervical intraepithelial neoplasia 2 and 3, and aged 18 to 55 years will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 58 patients with cervical intraepithelial neoplasia 2 and 3 of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Participants will be assigned to receive either vitamin D supplements (intervention group: n=29) and placebo (control group: n=29). Fasting blood samples will be taken at baseline and after 6-mo intervention. Start and end date of intervention: 6 months. Outcomes: Metabolic profiles will be meseaured at study baseline and end-of-trial.
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Objective: The aim of this study is to determine the effects of vitamin D supplementation on recurrence and metabolic profiles in women with cervical intraepithelial neoplasia 2 and 3. Study design: Parallel double-blind (both participants and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Women with cervical intraepithelial neoplasia 2 and 3, and aged 18 to 55 years will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 58 patients with cervical intraepithelial neoplasia 2 and 3 of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Participants will be assigned to receive either vitamin D supplements (intervention group: n=29) and placebo (control group: n=29). Fasting blood samples will be taken at baseline and after 6-mo intervention. Start and end date of intervention: 6 months. Outcomes: Metabolic profiles will be meseaured at study baseline and end-of-trial.
هدف: هدف این مطالعه تعیین اثرات مکمل یاری ویتامین D بر عود و پروفایل های متابولیک در زنان مبتلا به نئوپلازی داخل اپی تلیالی سرویکس درجه 2 و 3 است. طراحي انجام مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم شرکت کنندگان و هم محققان) موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: زنان مبتلا به نئوپلازی داخل اپی تلیالی سرویکس درجه 2 و 3 در محدوده سنی 18 تا 55 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 58 بیمار مبتلا به نئوپلازی داخل اپی تلیالی سرویکس درجه 2 و 3 واجد شرایط و ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: شرکت کنندگان برای دریافت مکمل ویتامین D (گروه مداخله:29=n) و پلاسبو (گروه کنترل: 29=n) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 6 ماه بعد از مداخله از شرکت کنندگان گرفته خواهد شد. زمان مداخله: 6 ماه. پيامدها: پروفایل های متابولیک در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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هدف: هدف این مطالعه تعیین اثرات مکمل یاری ویتامین D بر عود و پروفایل های متابولیک در زنان مبتلا به نئوپلازی داخل اپی تلیالی سرویکس درجه 2 و 3 است. طراحي انجام مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم شرکت کنندگان و هم محققان) موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: زنان مبتلا به نئوپلازی داخل اپی تلیالی سرویکس درجه 2 و 3 در محدوده سنی 18 تا 55 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 58 بیمار مبتلا به نئوپلازی داخل اپی تلیالی سرویکس درجه 2 و 3 واجد شرایط و ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: شرکت کنندگان برای دریافت مکمل ویتامین D (گروه مداخله:29=n) و پلاسبو (گروه کنترل: 29=n) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 6 ماه بعد از مداخله از شرکت کنندگان گرفته خواهد شد. زمان مداخله: 6 ماه. پيامدها: پروفایل های متابولیک در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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Objective: The aim of this study is to determine the effects of vitamin D supplementation on recurrence and metabolic profiles in women with cervical intraepithelial neoplasia 2 and 3.
Objective: The aim of this study is to determine the effects of vitamin D supplementation on recurrence and metabolic profiles in women with cervical intraepithelial neoplasia 2 and 3.
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هدف: هدف این مطالعه تعیین اثرات مکمل یاری ویتامین D بر عود و پروفایل های متابولیک در زنان مبتلا به نئوپلازی داخل اپی تلیالی سرویکس درجه 2 و 3 است.
هدف: هدف این مطالعه تعیین اثرات مکمل یاری ویتامین D بر عود و پروفایل های متابولیک در زنان مبتلا به نئوپلازی داخل اپی تلیالی سرویکس درجه 2 و 3 است.
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In this randomized double-blind placebo-controlled trial, patients will be assigned into two groups to receive vitamin D supplements or placebo.
In this randomized double-blind placebo-controlled trial, patients will be assigned into two groups to receive vitamin D supplements or placebo.
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در این مطالعه کارآزمایی بالینی دو سوکور کنترل شده با دارونما، بیماران به دو گروه برای دریافت مکمل یاری ویتامین دی یا پلاسبو اختصاص داده خواهند شد.
در این مطالعه کارآزمایی بالینی دو سوکور کنترل شده با دارونما، بیماران به دو گروه برای دریافت مکمل یاری ویتامین دی یا پلاسبو اختصاص داده خواهند شد.
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58 women with CIN2-3 eligible and referred to Oncology Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
58 women with CIN2-3 eligible and referred to Oncology Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
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58 زن مبتلا به نئوپلازی داخل اپی تلیالی سرویکس درجه 2-3 واجد شرایط و ارجاع شده به کلینیک انکولوژی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد.
58 زن مبتلا به نئوپلازی داخل اپی تلیالی سرویکس درجه 2-3 واجد شرایط و ارجاع شده به کلینیک انکولوژی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد.
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Patients aged between 25 and 65 years with CIN2-3 will be included. The exclusion criteria will be as follows: women who had a history of cervical cancer or other cancers of the lower genital tract, a history of hysterectomy or destructive therapy of the cervix and pregnant women.
Patients aged between 25 and 65 years with CIN2-3 will be included. The exclusion criteria will be as follows: women who had a history of cervical cancer or other cancers of the lower genital tract, a history of hysterectomy or destructive therapy of the cervix and pregnant women.
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بیماران مبتلا به CIN2-3 در سنین 25 تا 65 سال وارد مطالعه خواهند شد. معیارهای خروج از مطالعه به شرح زیر خواهد بود: زنانی که سابقه سرطان دهانه رحم یا سایر سرطانهای دستگاه تناسلی تحتانی ، سابقه هیسترکتومی یا درمان تهاجمی گردن رحم داشته باشند و زنان باردار
بیماران مبتلا به CIN2-3 در سنین 25 تا 65 سال وارد مطالعه خواهند شد. معیارهای خروج از مطالعه به شرح زیر خواهد بود: زنانی که سابقه سرطان دهانه رحم یا سایر سرطانهای دستگاه تناسلی تحتانی ، سابقه هیسترکتومی یا درمان تهاجمی گردن رحم داشته باشند و زنان باردار
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Patients will be assigned to receive either 50000 IU vitamin D supplement every 2 weeks (intervention group: n=29) or placebo (control group: n=29).
Patients will be assigned to receive either 50000 IU vitamin D supplement every 2 weeks (intervention group: n=29) or placebo (control group: n=29).
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بیماران برای دریافت مکمل 50000 واحد ویتامین دی هر دو هفته (گروه مداخله: 29=n) یا پلاسبو (گروه کنترل: 29=n) تقسیم خواهند شد.
بیماران برای دریافت مکمل 50000 واحد ویتامین دی هر دو هفته (گروه مداخله: 29=n) یا پلاسبو (گروه کنترل: 29=n) تقسیم خواهند شد.
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Fasting blood samples will be taken at baseline and after 6 months of intervention to measure metabolic profiles. Baseline and End-of-trial fasting plasma glucose (FPG), serum insulin, lipid profiles and hs-CRP levels.
Fasting blood samples will be taken at baseline and after 6 months of intervention to measure metabolic profiles. Baseline and End-of-trial fasting plasma glucose (FPG), serum insulin, lipid profiles and hs-CRP levels.
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نمونه خون ناشتا در ابتدای مطالعه و 6 ماه بعد از مداخله برای تعیین پروفایل های متابولیک از بیماران گرفته خواهد شد. گلوکز پلاسمایی ناشتا، سطوح سرمی انسولین، پروفایل های لیپیدی و hs-CRP، در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
نمونه خون ناشتا در ابتدای مطالعه و 6 ماه بعد از مداخله برای تعیین پروفایل های متابولیک از بیماران گرفته خواهد شد. گلوکز پلاسمایی ناشتا، سطوح سرمی انسولین، پروفایل های لیپیدی و hs-CRP، در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
General information
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Women with cervical intraepithelial neoplasia 2 and 3
Aged 25 to 65 years old
Women with cervical intraepithelial neoplasia 2 and 3 Aged 25 to 65 years old
زنان مبتلا به نئوپلازی داخل اپی تلیالی سرویکس درجه 2 و 3
در محدوده سنی 25 تا 65 سال
زنان مبتلا به نئوپلازی داخل اپی تلیالی سرویکس درجه 2 و 3 در محدوده سنی 25 تا 65 سال
Women who had a history of cervical cancer or other cancers of the lower genital tract
History of hysterectomy or destructive therapy of the cervix
Pregnant women
Women who had a history of cervical cancer or other cancers of the lower genital tract History of hysterectomy or destructive therapy of the cervix Pregnant women
زنانی که سابقه سرطان دهانه رحم یا سایر سرطانهای دستگاه تناسلی داشتند
سابقه هیسترکتومی یا درمان تهاجمی گردن رحم
زنان باردار
زنانی که سابقه سرطان دهانه رحم یا سایر سرطانهای دستگاه تناسلی داشتند سابقه هیسترکتومی یا درمان تهاجمی گردن رحم زنان باردار
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Oncology Clinic at the Kashan University of Medical Sciences, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Oncology Clinic at the Kashan University of Medical Sciences, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک انکولوژی در دانشگاه علوم پزشکی کاشان که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، به شرکت کنندگان در مطالعه، بطری های شماره گذاری شده کپسول ها را تخصیص خواهد داد.
تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک انکولوژی در دانشگاه علوم پزشکی کاشان که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، به شرکت کنندگان در مطالعه، بطری های شماره گذاری شده کپسول ها را تخصیص خواهد داد.
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t study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either vitamin D supplements (n = 29) or placebo (n = 29). Randomization will be done by the use of computer-generated random numbers.
t study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either vitamin D supplements (n = 29) or placebo (n = 29). Randomization will be done by the use of computer-generated random numbers.
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در ابتدای مطالعه و بعد از طبقه بندی بر اساس مقادیر پایه نمایه توده بدنی و سن، افراد به طور تصادفی به دو گروه برای دریافت مکمل ویتامین دی (n = 29) و پلاسبو (n = 29) تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
در ابتدای مطالعه و بعد از طبقه بندی بر اساس مقادیر پایه نمایه توده بدنی و سن، افراد به طور تصادفی به دو گروه برای دریافت مکمل ویتامین دی (n = 29) و پلاسبو (n = 29) تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Oncology Clinic at the Kashan University of Medical Sciences, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Oncology Clinic at the Kashan University of Medical Sciences, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
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تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک انکولوژی در دانشگاه علوم پزشکی کاشان که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، به شرکت کنندگان در مطالعه، بطری های شماره گذاری شده کپسول ها را تخصیص خواهد داد.
تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک انکولوژی در دانشگاه علوم پزشکی کاشان که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، به شرکت کنندگان در مطالعه، بطری های شماره گذاری شده کپسول ها را تخصیص خواهد داد.
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Secondary outcomes
#1
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Malondialdehyde
Malondialdehyde
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مالون دی آلدئید
مالون دی آلدئید
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At the beginning of the study and after 6 months of intervention
At the beginning of the study and after 6 months of intervention
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در ابتدای مطالعه و 6 ماه بعد از مداخله
در ابتدای مطالعه و 6 ماه بعد از مداخله
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Spectrophotometry
Spectrophotometry
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اسپکتروفتومتری
اسپکتروفتومتری
#2
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Fasting blood sugar
Fasting blood sugar
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قند خون ناشتا
قند خون ناشتا
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At the beginning of the study and after 6 months of intervention
At the beginning of the study and after 6 months of intervention
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در ابتدای مطالعه و 6 ماه بعد از مداخله
در ابتدای مطالعه و 6 ماه بعد از مداخله
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Baseline and End-of-trial
Baseline and End-of-trial
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کیت آنزیمی
کیت آنزیمی
#3
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Serum vitamin D
Serum vitamin D
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ویتامین دی سرمی
ویتامین دی سرمی
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At the beginning of the study and after 6 months of intervention
At the beginning of the study and after 6 months of intervention
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در ابتدای مطالعه و 6 ماه بعد از مداخله
در ابتدای مطالعه و 6 ماه بعد از مداخله
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Elisa kit
Elisa kit
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کیت الایزا
کیت الایزا
#4
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HDL
HDL
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HDL
HDL
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At the beginning of the study and after 6 months of intervention
At the beginning of the study and after 6 months of intervention
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در ابتدای مطالعه و 6 ماه بعد از مداخله
در ابتدای مطالعه و 6 ماه بعد از مداخله
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Enzymatic kit
Enzymatic kit
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کیت آنزیمی
کیت آنزیمی
#5
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Insulin resistance
Insulin resistance
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مقاومت به انسولین
مقاومت به انسولین
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At the beginning of the study and after 6 months of intervention
At the beginning of the study and after 6 months of intervention
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در ابتدای مطالعه و 6 ماه بعد از مداخله
در ابتدای مطالعه و 6 ماه بعد از مداخله
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Calculation using HOMA formula
Calculation using HOMA formula
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محاسبه با استفاده از فرمول HOMA
محاسبه با استفاده از فرمول HOMA
Recruitment centers
#1
Name of recruitment center - English: Naghavi Clinic
Name of recruitment center - Persian: کلینیک نقوی
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Naghavi oncology Clinic
Name of recruitment center - Persian: کلینیک انکولوژی نقوی
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5546 3378
Fax:
Email: asemi_r@yahoo.com
Web page address:
Name of recruitment center - English: Naghavi oncology Clinic Name of recruitment center - Persian: کلینیک انکولوژی نقوی Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8115187159 Phone: +98 31 5546 3378 Fax: Email: asemi_r@yahoo.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research, Kashan University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Gholamali Hamidi
Full name of responsible person - Persian: غلامعلی حمیدی
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research, Kashan University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Gholamali Hamidi
Full name of responsible person - Persian: غلامعلی حمیدی
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5546 3378
Fax:
Email: hamidi-gh@kaums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor for research, Kashan University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Gholamali Hamidi Full name of responsible person - Persian: غلامعلی حمیدی Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8115187159 Phone: +98 31 5546 3378 Fax: Email: hamidi-gh@kaums.ac.ir Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English:
Full name of responsible person - Persian:
Position - English:
Position - Persian:
Latest degree:
Area of specialty/work:
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English:
Street address - Persian:
City - English:
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contact.provinces_available:
Country:
Postal code:
Phone:
Mobile:
Fax:
Email:
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: Associate professor
Position - Persian: دانشیار
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Bolvare Ghotbe Ravandi, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5546 3378
Mobile: 00
Fax:
Email: asemi_r@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Position - English: Associate professor Position - Persian: دانشیار Latest degree: phd Area of specialty/work: 34 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Bolvare Ghotbe Ravandi, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8115187159 Phone: +98 31 5546 3378 Mobile: 00 Fax: Email: asemi_r@yahoo.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: دکتری تغذیه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: دکتری تغذیه
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_r@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Kashan University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Position - English: PhD of Nutrition Position - Persian: دکتری تغذیه Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8115187159 Phone: +98 31 5546 3378 Mobile: +98 913 361 5446 Fax: Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: دکتری تغذیه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: دکتری تغذیه
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_r@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Kashan University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Position - English: PhD of Nutrition Position - Persian: دکتری تغذیه Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8115187159 Phone: +98 31 5546 3378 Mobile: +98 913 361 5446 Fax: Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com Web page address:
Sharing plan
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
empty
Undecided - It is not yet known if there will be a plan to make this available.
Undecided - It is not yet known if there will be a plan to make this available.
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هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست.
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست.
Protocol summary
Study aim
Objective: The aim of this study is to determine the effects of vitamin D supplementation on recurrence and metabolic profiles in women with cervical intraepithelial neoplasia 2 and 3.
Design
In this randomized double-blind placebo-controlled trial, patients will be assigned into two groups to receive vitamin D supplements or placebo.
Settings and conduct
58 women with CIN2-3 eligible and referred to Oncology Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
Participants/Inclusion and exclusion criteria
Patients aged between 25 and 65 years with CIN2-3 will be included. The exclusion criteria will be as follows: women who had a history of cervical cancer or other cancers of the lower genital tract, a history of hysterectomy or destructive therapy of the cervix and pregnant women.
Intervention groups
Patients will be assigned to receive either 50000 IU vitamin D supplement every 2 weeks (intervention group: n=29) or placebo (control group: n=29).
Main outcome variables
Fasting blood samples will be taken at baseline and after 6 months of intervention to measure metabolic profiles. Baseline and End-of-trial fasting plasma glucose (FPG), serum insulin, lipid profiles and hs-CRP levels.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT201601045623N65
Registration date:2016-01-04, 1394/10/14
Registration timing:registered_while_recruiting
Last update:2019-09-23, 1398/07/01
Update count:1
Registration date
2016-01-04, 1394/10/14
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of vitamin D supplementation compared with the placebo on recurrence and metabolic profiles in women with cervical intraepithelial neoplasia 2 and 3
Public title
Effect of supplementation in treatment of women with cervical intraepithelial neoplasia 2 and 3
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with cervical intraepithelial neoplasia 2 and 3
Aged 25 to 65 years old
Exclusion criteria:
Women who had a history of cervical cancer or other cancers of the lower genital tract
History of hysterectomy or destructive therapy of the cervix
Pregnant women
Age
From 25 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
t study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either vitamin D supplements (n = 29) or placebo (n = 29). Randomization will be done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Oncology Clinic at the Kashan University of Medical Sciences, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
Placebo
Used
Assignment
Parallel
Other design features
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Oncology Clinic at the Kashan University of Medical Sciences, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2015-12-22, 1394/10/01
Ethics committee reference number
IR.Kaums.REC.1394.129
Health conditions studied
1
Description of health condition studied
Cervical intraepithelial neoplasia 2 and 3
ICD-10 code
C53.9
ICD-10 code description
Cervix uteri, unspecified
Primary outcomes
1
Description
Recurrence
Timepoint
Six months after intervention
Method of measurement
Colposcopy
Secondary outcomes
1
Description
Insulin
Timepoint
At the beginning of the study and after 6 months of intervention
Method of measurement
Elisa kit
2
Description
Nitric oxide
Timepoint
At the beginning of the study and after 6 months of intervention
Method of measurement
Spectrophotometry
3
Description
hs-CRP
Timepoint
At the beginning of the study and after 6 months of intervention
Method of measurement
Elisa kit
4
Description
Triglycerides
Timepoint
At the beginning of the study and after 6 months of intervention
Method of measurement
Enzymatic kit
5
Description
Cholesterol
Timepoint
At the beginning of the study and after 6 months of intervention
Method of measurement
Enzymatic kit
6
Description
Total antioxidant
Timepoint
At the beginning of the study and after 6 months of intervention
Method of measurement
Spectrophotometry
7
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 6 months of intervention
Method of measurement
Spectrophotometry
8
Description
Fasting blood sugar
Timepoint
At the beginning of the study and after 6 months of intervention
Method of measurement
Baseline and End-of-trial
9
Description
Serum vitamin D
Timepoint
At the beginning of the study and after 6 months of intervention
Method of measurement
Elisa kit
10
Description
HDL
Timepoint
At the beginning of the study and after 6 months of intervention
Method of measurement
Enzymatic kit
11
Description
Insulin resistance
Timepoint
At the beginning of the study and after 6 months of intervention
Method of measurement
Calculation using HOMA formula
Intervention groups
1
Description
Intervention group: Vitamin D supplement, 50000 IU, every 2 weeks, for 6 months orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo, every 2 weeks, for 6 months orally.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi oncology Clinic
Full name of responsible person
Zatollah Asemi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
asemi_r@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
hamidi-gh@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
asemi_r@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Fax
Email
asemi_r@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Fax
Email
asemi_r@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available